UK-REBOA: The UK Resuscitative Endovascular Balloon Occlusion of the Aorta
REBOA is currently used in a small number of trauma centres in the USA, France, Scandinavia, and Japan, and in a single centre in the UK. Whilst REBOA has shown early promise, recent observational studies have provided conflicting evidence as to its potential benefits. A robust evaluation of its feasibility, safety, efficacy and cost-effectiveness is urgently required.
The study will randomise a maximum of 120 patients from 10 large MTCs across the UK. The total sample size is constrained by the limited number of centres and the relative infrequency of trauma patients with life-threatening torso haemorrhage. Due to this constrained sample size we have adopted a Bayesian group-sequential trial design.
The study will include a full economic evaluation conducted alongside a Bayesian group-sequential randomised controlled trial. The primary economic outcome will be lifetime incremental cost per Quality Adjusted Life Year (QALY) gained, from a health care provider perspective and from a personal perspective (time to return to work or usual activities). Routine data will be collected where possible alongside the trial to estimate resource use with minimal patient burden. The 6 month follow up will include quality of life and return to normal activities questionnaires. A Markov decision analysis model will be used to extrapolate short term trial outcomes over a lifetime horizon. The project will also report data on shorter term (six month) costs to the NHS, mortality, EQ-5D-5L and extended Glasgow Outcome Score (GOS-E) at 6 month follow up. A value of information analysis will be included to assess the need for further research to address any remaining uncertainty in cost-effectiveness.
HERU researchers involved in this research project: Dwayne Boyers
External Collaborators: Prinicipal Investigators: Jansen, J. and Campbell, M. (University of Aberdeen)
More information about this project is available on the REBOA project website.
Jansen, J.O., Pallmann, P., Maclennan, G., Campbell, M.K. and the UK-REBOA Trial Investigators (Boyers, D. and Scotland, G. are on the trial team). (2017) 'Bayesian clinical trial designs: another option for trauma trials?', Journal of Trauma and Acute Care Surgery, 83(4), 736-741.